Consumers need to be able to rely on a brand’s reputation to ensure that the products they purchase are not misbranded, adulterated, or contaminated. Until now, the risk-based approach to food safety has attempted to tip the balance between probability and consequences to reduce risk with controls and inspections--a good, dependable approach, no one would argue.
But, too much regulation can hamper progress and innovation. Moreover, impulsive responses to audit findings can be prohibitively expensive, only to later prove ineffective at solving the problem. Quality cannot be inspected in. Rather, true quality must take a proactive route to maintaining regulatory compliance and consistent delivery of wholesome products.
Introducing Quality By Design, a solution borne by blending Lean principles and “roll-your-sleeves-up” resolve to get it right the first time; the foolproof pudding of the dietary supplement manufacturing industry. Quality by Design springs off of the premise that an ounce of prevention is worth a pound of cure. It draws heavily from an indoctrinated cultural and philosophical system that is painstakingly cultivated through training of all departments and employees. It designs and implements controls targeted at specific, recurring problems and sets meaningful specifications.
Quality by design enables pit-stop fixes so that errors are never passed to the internal customer downstream, whether that be warehousing, processing, or shipping. It anticipates pitfalls before they arise and allocates measures and controls to sidestep them altogether. The application of Lean principles radically simplifies the equation: compressed lead times result in shorter feedback loops. When turn-around times are reduced to days, there is no time for non-conformances to slip to the back burner. Rather, they must be remedied quickly, leaving little for the investigation trail to grow cold. Thus, short feedback loops provide for efficient troubleshooting and resolution.
Less is more—the application of LEAN means less raw material inventory, work-in-progress (WIP), and finished goods to worry about and manage, leaving more time to focus on real and lasting innovation. Materials don’t have time to expire, accumulate dust, or walk away. WIP and finished goods are promptly packaged and shipped, leaving little chance for mix-ups or adulteration. Quality by design eliminates waste and redundancy and more reliably and consistently delivers the quality products that bolster consumer confidence in a brand and keep them coming back.
To learn how the principles of Quality by Design can accelerate your business, visit www.genysisgroup.com.
Daisy brings with her 25 years of experience in scientific research and 10 years of experience designing, implementing, and managing quality assurance and quality control programs in the areas of food, dietary supplements, animal nutrition, medical devices, pharmaceuticals, and Ayurvedic medicine. Daisy holds a Master’s degree from the University of Utah and bears a track record of bringing existing systems into compliance and piloting toward exceptional standards.